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Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen:

Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transforaminal Lumbar Interbody Fusion

Intervention: Acetaminophen (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Texas Tech University Health Sciences Center

Official(s) and/or principal investigator(s):
Jason Felton, MD, Principal Investigator, Affiliation: TTUHSC department of Surgery

Overall contact:
Thu Fenno, Phone: 8067434222, Ext: 223, Email: thu.fenno@ttuhsc.edu

Summary

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Clinical Details

Official title: Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen: A Prospective, Randomized, Double Blind, Placebo-controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: VAS

Secondary outcome:

Sedation

Vital signs

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age > 18 years old

- Being scheduled to have elective primary minimally invasive 1 or 2 level

transforaminal lumbar laminectomy interbody fusion

- ASA I, II, or III

- Informed consent form signed

Exclusion Criteria:

- Anyone weighing less than 50kg (as this would require a dosing change).

- Hypersensitivity or contraindication to intravenous acetaminophen or opioids

- Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl

- Impairment of liver function-- defined as the inability to receive intravenous

acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart

- Mental retardation recorded as a diagnosis in the patient's chart

- History of chronic pain (defined as currently receiving treatment from a specialist

for pain)

- History of pain recalcitrant to intravenous morphine

- Impaired kidney function (defined as creatinine > 1. 5)

- Anyone who is not a candidate for general anesthesia or any other portion of the

investigator's standard of

Locations and Contacts

Thu Fenno, Phone: 8067434222, Ext: 223, Email: thu.fenno@ttuhsc.edu

Texas Tech University Health Science Center, Lubbock, Texas 79430, United States; Recruiting
Thu Fenno, Phone: 806-743-4222, Ext: 223, Email: thu.fenno@ttuhsc.edu
Jaime Villarreal, MD, Sub-Investigator
Additional Information

Starting date: October 2013
Last updated: April 9, 2015

Page last updated: August 23, 2015

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